BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG 45 ENDOCUTTER

    MDR report key: 1831677 · Received September 12, 2007

    Report

    Report Number
    1527736-2007-05989
    Event Type
    Malfunction
    Date Received
    September 12, 2007
    Date of Event
    July 31, 2007
    Report Date
    August 3, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH THE FIRING MECHANISM DAMAGED AND WITH NO CARTRIDGE PRESENT. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE LEFT SHROUD PINION AXLE SUPPORT WAS FOUND DAMAGED, NO FUNCTIONAL TEST WAS PERFORMED. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED PROSTATECTOMY PROCEDURE, THE DEVICE LOCKED OUT. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG 45 ENDOCUTTER GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA

    Patients

    Seq Age Sex Outcome Treatment
    1